Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BCMA/CD70 CAR-T cells · 1 trial · 1 indication
Types, frequency and severity of adverse events.
Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K) is from 0 to 105 points. The higher score means the stronger disease activity.
Physician Global Assessment(PGA) is a continuous visual analogue scale with 0, 1, 2, and 3 scales. "0" indicates no disease activity and "3" indicates the most severe disease activity.
British Isles Lupus Assessment Group Index 2004(BILAG-2004) consists of 8 systems, each of which is classified as A, B, C and D respectively. "A" indicates that the condition is highly active and requires active treatment. "B" indicates that the condition is active and requires close monitoring or symptomatic treatment. "C" indicates a stable condition. "D" indicates that the system is not involved.
The definition of SRI-4 response: SLEDAI-2K ≥ 4-Point improvement; PGA with no worsening (\<0.3 point increase); BILAG 2004 with no new A domain score and no more than 1 new B domain scores.
The definition of LLDAS: SLEDAI-2K ≤ 4 and no disease activity in major organs (kidneys, central nervous system, heart and lungs), and no vasculitis or fever; no new disease activity symptoms were added compared with previous disease assessments; PGA ≤ 1; irrespective of serology; with permitted use of low-dose glucocorticoids (prednisolone ≤ 7.5 mg/day), and/or stable immunosuppressives and biologics.
The definition of DORIS: SLEDAI-2K = 0 ; PGA \< 0.5 ; irrespective of serology; with permitted use of antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
| Arm | Type | Description |
|---|---|---|
| CAR-T treatment group | EXPERIMENTAL | This trial was designed as an open, single-arm, single-center, dose-increasing trial. |
| Name | Type | Description |
|---|---|---|
| BCMA/CD70 CAR-T cells | BIOLOGICAL | Three dose groups (1.5×10\^5/kg, 5×10\^5/kg, 10×10\^5/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose. |
Inclusion Criteria: * Age ≥ 18 years old; * Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria, and still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod), and/or hydroxychlor...
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| Bristol-Myers Squibb Company | BMY | 7 | PHASE3 | Deucravacitinib |
| Viatris, Inc. | VTRS | 5 | PHASE3 | Cenerimod |
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Ianalumab |
| AstraZeneca PLC | AZN | 21 | PHASE3 | Medi-546 |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Upadacitinib |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Belimumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | SAR441344 |
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| Alumis Inc. | ALMS | 1 | PHASE2 | Envudeucitinib |
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| Amgen Inc. | AMGN | 1 | PHASE2 | Inebilizumab, Blinatumomab |
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| Eli Lilly and Company | LLY | 1 | PHASE1 | LY4298445 |
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| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
BCMA/CD70 CAR-T cells is an investigational cell therapy being studied for autoimmune diseases, specifically Juvenile Dermatomyositis (JDM) and Systemic Lupus Erythematosus (SLE). It is in Phase 1 clinical development for these conditions, with trials also exploring its use in polyarticular juvenile idiopathic arthritis and systemic sclerosis.
BCMA/CD70 CAR-T cells targets two proteins, BCMA and CD70, which are expressed on certain immune cells. By engineering a patient's T cells to recognize these targets, the therapy aims to eliminate disease-driving cells in autoimmune conditions like lupus and juvenile dermatomyositis.
BCMA/CD70 CAR-T cells is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker DTIL. The company is conducting Phase 1 clinical trials for this investigational therapy in autoimmune indications.
BCMA/CD70 CAR-T cells is in Phase 1 clinical development. It is an investigational therapy, not yet approved by regulatory authorities. Two Phase 1 trials are currently recruiting participants to evaluate its safety and preliminary efficacy in autoimmune diseases.
BCMA/CD70 CAR-T cells is being studied in two Phase 1 trials: NCT07184450 for refractory pediatric rheumatic diseases including juvenile dermatomyositis, and NCT07318259 for refractory systemic lupus erythematosus. Both trials are recruiting in China and are uncontrolled, non-randomized studies.
Yes, BCMA/CD70 CAR-T cells is also known as BCMA/CD70-targetd CAR-T. These names refer to the same investigational cell therapy being developed by Precision BioSciences for autoimmune conditions.